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Description
This webinar describes exactly what is required for compliance with Computer Software Assurance guidance, 21 CFR Part 11, and the European equivalent, Annex 11, for local and SaaS/Cloud-hosted applications. It explains how to write a Data Privacy Statement for compliance with the EU General Data Protection Regulation (GDPR). What the regulations mean is described for all four primary compliance areas: SOPs, software features, infrastructure qualification, and validation. It gets you on the right track for using electronic records and signatures to greatly increase productivity and ensure compliance.
Speaker
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David Nettleton CPMSM, PESC is an expert in credentialing and provider/payer enrollment with over 23 years of experience in the healthcare industry. David Nettleton has a deep understanding of Medicare & Medicaid enrollment and is a nationally certified credentialing manager and provider enrollment specialist. Through, YS Credentialing PLLC, David Nettleton... Read more
Learning Objectives
- Which data and systems are subject to Part 11 and Annex 11
- Impact of Electronic Systems…Clinical Investigations Q&A Guidance for Industry Oct 2024
- What the regulations mean, not just what they say
- Avoid 483 and Warning Letters
- Requirements for local, SaaS, and cloud hosting
- Understand the current industry standard software features for security, data transfer, audit trails, and electronic signatures
- How to use electronic signatures, ensure data integrity, and protect intellectual property
- SOPs required for the IT infrastructure
- Product features to look for when purchasing COTS software
- Reduce validation resources by using easy-to-understand fill-in-the-blank validation documents
- How to write a Data Privacy Statement.
Areas Covered
- What 21 CFR Part 11 means today
- Purpose of Part 11
- What does Part 11 mean?
- SOPs
- System features
- Infrastructure qualification
- Validation
- Security standards
- Roles
- Usernames and passwords
- Restrictions and logs
- Data transfer standards
- Deleting data
- Encryption
- Audit trail standards
- Types of data
- High risk systems
- Electronic approval standards
- Electronic signatures
- Single sign-on
- Replacing paper with electronic forms
- Infrastructure qualification
- How to document qualifications efficiently
- Validation
- Software validation for vendors
- Computer system validation for users
- Fill-in-the-blank templates
- Change control re-validation
- SaaS/Cloud hosting
- Responsibilities for software vendor and hosting provider
- Evaluation criteria
- Hosting requirements
- SOPs
- IT, QA, validation
- Software development
- Annex 11
- Comparison with Part 11
- EU GDPR
- Data Privacy Statement.
Who Should Attend
- GMP, GCP, GLP, regulatory professionals
- QA/QC
- IT
- Auditors
- Managers and directors
- Software vendors, hosting providers.